Identity
- Trade Name
- Diazyme FDA UDI
- Generic Name
- Lithium therapeutic drug monitoring IVD, calibrator FDA UDI
- Model / Reference
- DZ116B-CAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817089020412 FDA UDI
- GMDN Term
- Lithium therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lithium therapeutic drug monitoring IVD, calibrator
Diazyme by Diazyme Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lithium therapeutic drug monitoring IVD, calibrator.
- Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diazyme Laboratories, Inc.
Sources (1)
- FDA UDI 9985a0ba-26d4-4799-a621-6e3dd17f6119 32 fields · synced Jun 9, 2026